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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K033711
Device Name FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
Applicant
Fukuda Denshi USA, Inc.
17725 NE 65th St., Bldg. C
Redmond,  WA  98052
Applicant Contact LARRY D WALKER
Correspondent
Fukuda Denshi USA, Inc.
17725 NE 65th St., Bldg. C
Redmond,  WA  98052
Correspondent Contact LARRY D WALKER
Regulation Number870.1025
Classification Product Code
MHX  
Date Received11/26/2003
Decision Date 06/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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